FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CYBERSONIC
K Number: K980075
·
Decision Mar 4, 1998
Classifications
1
FEI Numbers
150
Registration Numbers
151
Same Product Code
30
Applicant Total
4
Review Days
55
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Basic Information
- Device Name
- CYBERSONIC
- K Number
- K980075
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6855
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- American Dentronics, Inc.
- Date Received
- January 8, 1998
- Decision Date
- March 4, 1998
- Product Code
- LCN
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LCN | Scraper, Tongue | FDA class 1 | Dental |
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